title: Adapted physical activity and diet (APAD) during adjuvant breast cancer therapy: design and implementation of a prospective randomized controlled trial.
abstract: Exercise practice and appropriate nutrition have been advanced as non pharmacological supportive care to reduce side effects related to cancer and its treatment, but large sample-sized randomized controlled trials are needed to confirm such results. The Adapted Physical Activity and Diet counseling (APAD) study is a prospective randomized controlled trial designed to evaluate the effectiveness of a 26-week hospital- and home-based lifestyle intervention on cancer-related fatigue in women receiving breast cancer adjuvant treatment (chemotherapy and radiotherapy). The aim of this paper is to describe the APAD study protocol. Study recruitment goal is 264 adult breast cancer women with newly, histologically proven, incident and non metastatic breast cancer scheduled for 6 cycles of adjuvant chemotherapy followed by radiotherapy. Patients are randomized either in the experimental arm with tailored exercise training and diet counseling program or in the control arm without any lifestyle intervention (usual care). Outcome measures are collected at baseline, and at 15 weeks (i.e., mid-intervention), 26 weeks (i.e., immediately post-intervention), and at 12-month and 18-month of follow-up. Intervention effect is assessed on fatigue (emotional, cognitive, physical), quality-of-life, anxiety, depression, body weight and composition. In addition, levels of physical activity, dietary intakes and adjuvant therapy observance are measured and a cost-utility analysis will be performed. If improvements in fatigue, quality-of-life and a better weight control are observed, the APAD study could demonstrate the feasibility and the effectiveness of such exercise and nutrition supportive care with limited additional cost in patients receiving adjuvant breast cancer therapy.
authors.affiliation: Laboratory Epsylon, EA 4556 Dynamics of Human Abilities & Health Behaviors, University of Montpellier, 4 boulevard Henri IV, F-34000 Montpellier, France; INSERM UMR 1027, Paul Sabatier University, 37 allées Jules Guesde, F-31000 Toulouse, France. Electronic address: marioncarayol@yahoo.fr.
authors.forename: Marion
authors.initials: M
authors.lastname: Carayol
authors.forename: Gilles
authors.initials: G
authors.lastname: Romieu
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Bleuse
authors.forename: Pierre
authors.initials: P
authors.lastname: Senesse
authors.forename: Sophie
authors.initials: S
authors.lastname: Gourgou-Bourgade
authors.forename: Chakib
authors.initials: C
authors.lastname: Sari
authors.forename: William
authors.initials: W
authors.lastname: Jacot
authors.forename: Hélène
authors.initials: H
authors.lastname: Sancho-Garnier
authors.forename: Chloé
authors.initials: C
authors.lastname: Janiszewski
authors.forename: Silène
authors.initials: S
authors.lastname: Launay
authors.forename: Florence
authors.initials: F
authors.lastname: Cousson-Gélie
authors.forename: Grégory
authors.initials: G
authors.lastname: Ninot
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000178:diet therapy / Q000628:therapy*; D002985:Clinical Protocols; D003376:Counseling; D004032:Diet / Q000379:methods; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D009043:Motor Activity; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
keywords: Breast cancer; Diet; Fatigue; Physical activity; Quality-of-life; Randomized controlled trial